7.  The applicant was born in 1967. After numerous previous failed attempts, the applicant became the mother of a child, conceived as the result of an in vitro fertilisation (IVF) procedure with donated gametes. The procedure was performed in S. Medical Centre in Bucharest; and produced nineteen embryos, three of which were implanted on 8 June 2008.
The remaining sixteen embryos obtained on the same occasion were frozen until the applicant was considered fit by her physician to undergo another pregnancy. A protocol was concluded between the applicant and S., in which the applicant acknowledged that she had been informed that in 15-20% of cases, after thawing, the embryos proved not to be viable, and that if that were the case the embryo transfer would be impossible.
8.  According to a document issued by the National Transplant Agency (“the NTA”), on 15 July 2009 the S. Medical Centre was authorised to function as a bank for genetic material. However, the circumstances in which that document was issued are currently under the scrutiny of the domestic criminal court, in view also of the fact that it was the Ministry of Public Health, and not the NTA, which had exclusive competence to give such authorisations.
9.  On 24 July 2009, the Directorate for the Investigation of Organised Crime and Terrorism attached to the Prosecutor General’s Office (DIICOT) closed the S. Medical Centre, seized all the genetic material found there and deposited it at the Mina Minovici Institute of Forensic Medicine (IFM). This decision was not contested before the courts.
10.  On 25 August 2009, the applicant wrote to DIICOT in her capacity as “owner of the sixteen embryos”, expressing concerns as to the state of her frozen embryos and asking to be informed of the practical procedure to be followed in order to urgently retrieve her embryos.
11.  On 7 September 2009, the applicant was informed by DIICOT that it was not aware of any technical means of identifying the embryos in question, given that an inventory was still being made of all the material seized and no document relating to the applicant’s embryos had been identified.
In any event, in order to be able to retrieve her genetic material from the Institute, the applicant was advised to appoint a doctor specialising in embryology, who would then contact the IFM for that purpose.
12.  In attempts to find an embryologist the applicant addressed her request to the Ministry of Health, the Embryologists’ Association and the National Doctors’ Association.
In its reply, the Ministry of Health gave the applicant a list of the medical institutions accredited as banks for genetic material, by virtue of ministerial Order no. 1225 of 1 July 2008; the S. Medical Centre and the IFM were not mentioned in the list. The Ministry also informed the applicant that it could not intervene in any way in the contractual relationship between her and S., assuming that such a contract existed and included specific provisions as to who could retrieve the embryos and under what circumstances. Referring to the letter of 7 September 2009 from DIICOT, the Ministry suggested that the applicant should contact S. and, on the basis of the contract she had concluded with the clinic, ask for support in identifying and retrieving her embryos.
The Embryologists’ Association replied to the applicant on 12 October 2009, informing her that an embryo transfer could be performed only by a specialist in assisted reproduction, and that such transfers could not be carried out until the relevant embryos had been properly identified.
13.  The applicant finally contacted two doctors from the P. Clinic in Sibiu (300 km from Bucharest). On 2 November 2009, in accordance with the legal requirements, the P. Clinic requested the authority of the NTA to perform the retrieval, but received no answer. The request was reiterated on 29 January 2010; on 1 February the NTA informed the P. Clinic that it could not grant the requested authority, since such authority could only be given in respect of a tissue and cell bank accredited by the NTA, which the IFM was not.
14.  On 10 February 2010, DIICOT informed the applicant that the NTA’s refusal was not binding on DIICOT; the IFM had been appointed as the legal custodian of the genetic material pending a criminal investigation. Once the investigation was terminated and the S. Clinic was indicted, the file was to be sent before the criminal courts on 24 February 2010. Consequently, an order was issued authorising the applicant to retrieve her embryos by 25 February 2010, since after that date the Institute for Forensic Medicine would cease to act as a deposit bank appointed by the investigating authorities. The applicant was required to be accompanied by an embryologist and to provide a special container with liquid nitrogen for the transfer.
15.  The applicant managed to obtain from a clinic in Austria a special container with liquid nitrogen of the kind required for such transfers and asked the clinic to carry out the transfer.
On 12 February 2010, the P. Clinic informed the applicant that the NTA had refused to consent to the transfer for the following reasons: the IFM had never been authorised by the NTA to store such materials and therefore there could be no guarantee as to the quality of the material stored there (against contamination, deterioration, and so on); moreover, the storage of such material in the Institute did not comply with the legal requirements (Order of the Minister of Public Health no. 1763/2007) concerning the traceability of the genetic material.
In view of the NTA’s refusal, of the fact that the P. Clinic carried out its activities under the authority of the NTA, and in so far as it could not guarantee the quality and security of the genetic material, the clinic informed the applicant that it could not proceed with the retrieval.
16.  On 19 February 2010 the applicant wrote again to DIICOT, asking it to issue an order allowing the IFM to continue to store her embryos until the NTA had consented to their retrieval. As justification of the need for such an urgent measure, the applicant pointed out that an inability to transfer the embryos would have serious repercussions on the right to life of her embryos and on her right to have a family.
On the same day, the applicant sent a similar letter to the NTA, asking it to re-evaluate the circumstances of her case and consequently to authorise the transfer of her embryos to the P. Clinic.
17.  The NTA replied on 23 February 2010, informing the applicant as follows: the IFM had been appointed as custodian in complete disregard of the legal provisions of Directive 2004/23/EC and of Article 148 (4) of the Health Reform Act (Law no. 95/2006); the IFM had never been accredited, nor had it been given approval by the NTA to operate as a bank for genetic material; the S. Medical Centre had been accredited to operate as a bank of genetic material only on 15 July 2009, and not in June 2008, when the embryos had been frozen and stored; the Code of Criminal Procedure, invoked by DIICOT, did not provide any safeguards as to the security and safety of the embryos while they were stored at S. (for one year) and subsequently at the IFM (for six months).
The NTA also contended that it did not have any information regarding the way in which the embryos had been transported from S. to the IFM, and was thus unable to guarantee that the minimum sanitary conditions had been complied with.
The NTA could therefore not authorise the transfer of the embryos from the IFM to another clinic, either within Romania or internationally; furthermore, according to the provisions of Article 19 (3) of Directive 2004/23/EC, “all tissue and cells that do not comply with [the legal] provisions shall be discarded.”
18.  On 18 February 2010, the applicant requested the Court under Rule 39 of the Rules of Court to direct the Romanian authorities to allow her to retrieve her sixteen embryos stored at the Institute of Forensic Medicine.
19.  On 22 February 2010, the President of the Chamber to which the case had been allocated decided, in the interests of the parties and the proper conduct of the proceedings before the Court, to indicate to the Government of Romania, under Rule 39 of the Rules of Court, that the embryos should not be destroyed after 25 February 2010, for the duration of the proceedings before the Court.
The President also decided to request the Government, under Rule 54 § 2 (a) of the Rules of Court, to submit information as to the legal status of the embryos after 25 February 2010 and on the domestic law and procedure which would allow the applicant to obtain a court transfer order quickly.
20.  In reply, the Government informed the Court as follows.
21.  In its letter of 26 February 2010, the IFM informed the Government that it was merely the authorised depository of a receptacle seized by DIICOT from S., and that its only obligation was to make sure that the receptacle was preserved at a temperature of -80 degrees Celsius. The IFM therefore could not dispose of the biological material stored in the receptacle in any way.
22.  The Ministry of Public Health informed the Government on 8 March 2010 that they had asked the IFM to take all necessary measures to adequately preserve the applicant’s embryos. The Ministry also asked the NTA to share with the IFM all relevant information concerning the appropriate procedure for preserving the above-mentioned embryos.
23.  With regard to the information required under Rule 54 § 2 (a), the Government appended the letter of 8 March 2010 from DIICOT, which stated that the applicant’s request to have her genetic material returned had already been granted by the prosecutor on 12 November 2009. The decision had been taken after the applicant’s embryos had been identified on 5 November 2009; the applicant had been given until 25 February 2010 to retrieve her embryos, the same deadline having been set for four other individuals who were in a situation similar to the applicant’s, in view of the necessity of avoiding repeated interferences with the contents of the receptacles and the fact that since an indictment had already been issued, the investigation authorities could no longer pay the IFM the cost of storage.
DIICOT also informed the Government that the seizure, transport and handover of the genetic material to IFM had been carried out with the agreement of the Ministry of Public Health, whose representative – the manager of the NTA at that time – had cooperated directly with the investigation authorities.
24.  In conclusion, the Government contended that the applicant already had a decision allowing the transfer of the embryos, which could be carried out at any time provided the applicant was accompanied by an embryologist and had the appropriate receptacle.
25.  In response to the Government’s reply, the applicant asked the Court to note that it was not specified whether the applicant would be able to retrieve her embryos in the absence of authorisation from the NTA. In practice, as she had already shown, the embryo transfer was not possible unless the NTA authorised it.
26.  On 20 April 2010, the applicant formulated before the Bucharest County Court civil claims in the criminal proceedings pending before the domestic courts following the indictment issued by DIICOT (see paragraph 14 above); she thus asked the court to allow an embryo transfer from the IFM to a Romanian or foreign authorised clinic.
The applicant’s request was dismissed on 6 July 2010; the court considered that given that the prosecutor’s decision of 12 November 2009 had already granted her claim, the actual implementation and enforcement of the decision exceeded the framework of the criminal trial. The court also held that the applicant had the opportunity, if she so wished, to contest the NTA’s refusal to authorise the embryo transfer before the civil courts.
The applicant contested this ruling; on 23 July 2010 her appeal was dismissed as inadmissible by the Bucharest Court of Appeal. In the court’s reasoning it was stated that there was no legal basis to respond to her request within the criminal proceedings, the civil courts having jurisdiction to examine her complaints.
In his dissenting opinion, Judge D.D. estimated that the applicant’s request was well founded, in so far as, in spite of the prosecutor’s decision ordering the restitution of her embryos, the authorities were refusing to implement the decision. Having regard to the fact that the confiscation of the embryos was carried out within criminal proceedings, it was only natural that the restitution should also be carried out within the same proceedings. At the same time, considering that the applicant could not be held responsible for the confiscation, which had been ordered by the investigating authorities in the absence of any authorisation from the NTA, it was excessive to ask the applicant to pursue yet another set of proceedings in order to be able to obtain authorisation for transfer from the NTA.
27.  On 28 July 2010 the applicant lodged with the Bucharest Court of Appeal a request seeking to obtain, in accordance with the provisions of Law no. 554/2004 regulating administrative proceedings, the NTA’s authorisation for the transfer of her embryos to a specialised and authorised clinic, whether in Romania or abroad.
In their defence, the NTA reiterated their arguments, according to which the fact that the embryos had been deposited firstly at S., and then at the IFM, where they had been transported under unknown conditions, neither of the two institutions being at the time accredited as banks for genetic material, created uncertainty with regard to the safety and quality of the embryos (see also paragraph 17 above). In such circumstances, it was not possible to authorise transfer under the relevant legislation. Furthermore, if any clinic from Romania agreed to deposit the sixteen embryos, the NTA would have to revoke that clinic’s accreditation for non-compliance with the law.
The applicant’s request was dismissed as ill-founded on 10 December 2010. The court considered that in view of the relevant legislation, requiring specific standards of quality and safety with regard to the genetic material and in so far as neither the S. Clinic at the time of the original deposit of embryos nor the IFM, was accredited or authorised to function as banks of genetic material, the NTA’s refusal was justified and in accordance with the law.
28.  The applicant contested this judgment before the High Court of Cassation and Justice, reiterating that according to the Government’s submissions before the Court, the transfer of the embryos from the S. Clinic into the IFM was carried out with the approval of the Ministry of Health and of the NTA’s manager; in that respect, the NTA’s refusal to authorise a further transfer appeared unjustified. Furthermore, the applicant’s few visits to the IFM for the purposes of checking the state of her embryos revealed that the embryos were being kept in precarious conditions, in the absence of any trained staff able to properly supervise their preservation.
29.  The High Court gave its ruling on 17 May 2011, allowing the applicant’s request and obliging the NTA to authorise the transfer of the sixteen embryos from the IFM to an authorised clinic in Romania or abroad.
In its reasoning, the court mainly held that in so far as the NTA’s attribution was to coordinate the activities of procurement, processing, preservation, storage, validation and distribution of human tissue and cells in Romania, there was no legal ground for it to interfere in the implementation of the prosecutor’s decision to restore the embryos.
The fluctuating attitude of the NTA concerning its participation and/or cooperation with the criminal investigation authorities, namely, confirming that the retrieval of the embryos from S. had been done with the approval of the NTA’s manager, while also holding that the transfer had been made without its consent, proved once more that the NTA was confused and uncertain about the scope of its own authority. The NTA’s cooperation with the criminal investigation authorities was certain, as it came out especially from the observations submitted by the Government’s Agent before the Court (see paragraph 23 above). Such cooperation was, in any event, natural, having regard to the specific nature of the confiscated goods. In this context, the NTA should have advised the investigation authorities to deposit the embryos in an authorised clinic, which they did not do. On the contrary, the NTA proved to be excessively formalistic only when it came to the restitution of the embryos to the applicant, considering, unfoundedly, that it was within its competence to intervene in the enforcement of the prosecutor’s decision:
“This behaviour on the part of the NTA breached the applicant’s right to retrieve her embryos and to make use of them as urgently as possible, in view of the special characteristics of the genetic material and also of the applicant’s age, in the context of her desire to become a mother.”
30.  The NTA’s allegations, that in 2008, when the applicant underwent the IVF, she did not comply with the relevant legal requirements, were not in themselves relevant, in so far as the criminal proceedings regarding the activity of the S. Clinic were still pending; moreover, in 2008, when the applicant deposited her embryos at S., the clinic was in the process of being accredited, as shown by the inspections organised to that end on 24 June 2008, and 15 April and 13 July 2009 by the NTA and the Department for the Control of Public Health, culminating with the accreditation apparently having been granted to the clinic by the NTA on 15 July 2009.
In spite of all these factors, and of the fact that the prosecutor decided that the embryos should be given back to the applicant, the NTA unjustifiably intervened and blocked the restitution procedure; the NTA unlawfully arrogated to itself an authority it did not have, while also threatening any medical institution which could have received the embryos even without the NTA’s authorisation that in such a case their licence would be suspended or even revoked.
Furthermore, the NTA could not cite any doubt as to the security and quality of the genetic material because it had been deposited at the IFM, an unauthorised clinic, having regard to the fact that at the moment of the deposit their agreement had been given, and afterwards, following the Court’s request that the embryos should be preserved and protected pending the proceedings before this Court, the NTA was expressly solicited by the Ministry of Health to provide expertise so as to satisfy the Court’s request.
Referring to the case of Ternovszky v. Hungary (no. 67545/09, 14 December 2010), the High Court held that when there was no domestic law able to adequately define the specific circumstances in the relationship between an individual and the state, the latter was bound to protect fundamental human rights, such as, in the present case, the right to respect for private life and the right to life.
For this reason, the court considered that:
“By its obstructive attitude, the NTA infringed the applicant’s rights and interests linked to the right to a private life and the right to life, by not properly balancing the public interest that the NTA is bound to protect and the legitimate interests of the applicant.”
It therefore allowed the applicant’s claims as formulated, holding that
“the NTA was obliged to authorise the transfer of the sixteen embryos from the IFM to an authorised and specialised clinic in Romania or abroad, a clinic which would be able to receive the embryos in its bank and which would be able to assist the applicant with the desired embryo transfer.”
31.  In accordance with the High Court’s ruling, on 15 June 2011 the NTA issued a decision in which it “authorised the transfer of the sixteen embryos from the IFM Mina Minovici to an authorised clinic in Romania, in accordance with the relevant legal framework”.
The NTA further held that the second alternative mentioned in the High Court’s judgment, namely that the transfer could also be authorised abroad, could not be implemented, in so far as the appropriate authorisation for a transfer abroad was not an ordinary authorisation for transfer, but “an authorisation for export”, which was never requested as such by the applicant; moreover, authorisation for export had a very particular character, and in its absence the export of human tissues and cells was prohibited.
32.  Subsequently, the applicant unsuccessfully attempted to transfer her embryos to the B. clinic (a private clinic in Bucharest). In their response to the Government on why the transfer was not possible, on 6 October 2011 the B. Clinic informed that they could not proceed with the transfer without relevant medical information concerning the embryos and their medical history, including data on how they had been preserved from the very beginning. Consequently and having regard to the fact that the clinic did not have the special quarantine conditions needed for deposit of the embryos, the transfer could not be carried out in compliance with the applicable legal provisions.
33.  On 12 October 2011, a DIICOT prosecutor issued a decision, in which it was held that having regard to the High Court’s ruling and to the fact that the only State medical institutions accredited to function as “human cells and/or tissue banks” were respectively the Prof. Dr. Panait Sârbu Obstetrics and Gynaecology Hospital in Bucharest and the Emergency County Hospital in Cluj, for reasons of efficiency the first institution was to become the new custodian of the applicant’s embryos. The embryo transfer was to be carried out by a specialist transport company, the costs being borne by the DIICOT. All documents regarding the maintenance of the embryos were to be transferred to the new custodian.
The prosecutor’s decision was not contested by the applicant.
34.  In accordance with this decision, on 19 October 2011 the embryo transfer was carried out and the embryos placed in the Assisted Reproduction Laboratory within the Prof. Dr. Panait Sârbu Hospital, the newly appointed custodian. According to a letter sent by the Ministry of Health to the Government on 15 December 2011, the new custodian was accredited as a genetic bank and human cell and tissue bank, and was also authorised to assist the applicant with any procedure related to artificial insemination.
35.  In a letter of 11 November 2011, the applicant submitted that the transfer of the embryos had once more been carried out without her consent and even without her being consulted or informed in advance. She further stated that in the Prof. Dr. Panait Sârbu Hospital she had had bad experiences, in so far as in 2007 she underwent two unsuccessful IVF procedures there and therefore she could no longer trust the professional capacity of those doctors. She considered that she was entitled to be assisted for future IVF by doctors of her choice, in whom she trusted; therefore the transfer of her embryos into the above-mentioned clinic had denied her that right.
The applicant requested the opportunity to transfer her embryos to a clinic of her choice, at the expense of the Romanian authorities, who were responsible for the situation created and also for the well-being of her embryos.
36.  By a letter of 23 December 2011, the Prof. Dr. Panait Sârbu Hospital informed the applicant’s representative that from 16 January 2012 they could be contacted to set a date on which the applicant, in the presence of an embryologist, could come to take possession of her genetic material in order to transfer it elsewhere, in accordance with the applicable rules and regulations set by the NTA.
By a letter sent to the Court on 3 March 2012, the applicant stated that she had found a clinic outside Bucharest “willing to help” her and that a date of transfer was “hopefully” imminent. In the meantime, she had also tried to set up a new procedure in the hope of a new pregnancy. She further stressed the trauma she had gone through on account of the State’s successive interferences with her right to have another child by IVF.
37.  On 14 May 2012, the applicant alleged that she had contacted many clinics in Romania regarding the transfer of her embryos, but in spite of the fact that they were open to the idea at the beginning, “after further evaluation, the risk for them seemed to high” and no transfer was agreed.
38.  The Government replied that on one hand, the applicant’s assertions were too vague and unsubstantiated, and on the other hand, that she had not acted with specific diligence to transfer her embryos from Prof. Dr. Panait Sârbu clinic, either to start an IVF procedure or at least to get more information about how her embryos were being taken care of in that clinic.
On 19 June 2012, the Government sent a document issued by the Prof. Dr. Panait Sârbu clinic in which it was confirmed that the applicant could initiate an IVF procedure in that clinic, with the assistance of a doctor and an embryologist of her choice, whether from Romania or from abroad, in so far as these two had a license to practice in Romania. Furthermore, a letter from the private clinic M.N.L. in Bucharest was appended, stating that the clinic was willing to take the applicant’s embryos while its doctors would monitor both the patient and the embryo-transfer.
On 22 June 2012, the applicant met the manager of the M.N.L. clinic; following their discussion, she wrote a letter to the clinic in which she asked for more information concerning the concrete stages envisaged for the embryo transfer, as well as a precise date on which such a transfer could be accomplished.
39.  The Act is divided into seventeen titles, covering a wide array of subjects specific to the public health area. Title VI contains provisions covering the procurement and transplant of organs, tissues and cells of human origin used for therapeutic purposes, the donors of organs, tissues and human-origin cells, the donation and transplant thereof and the financing of transplant activity. It transposes into national legislation Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells. It also defines the role and responsibilities of the National Transplant Agency, as the main competent authority in the field of the procurement and transplant of organs, tissues and cells of human origin, including the accreditation, designation, authorization or licensing of tissue establishments and tissue and cell preparation processes.
Section 143
The National Transplant Agency shall be responsible for the coordination, supervision, approval and implementation of any provisions regarding transplant activities.
Section 148
(4)  Any transplant of tissue and cells of human origin may be processed only from the banks accredited or approved by the National Transplant Agency...
(9)  Imports or exports of tissue and cells shall be possible only if specifically authorised by the National Transplant Agency.
40.  This sets out provisions governing the mechanisms to be put into place to ensure the quality and safety of tissues and cells and their traceability, in compliance with the relevant European law requirements.
41.  This lists the tissue establishments accredited, designated, authorized or licensed to function as tissue and human cell banks and/or users. Neither the clinic S., nor the IFM appear in this Act.
42.  In its relevant parts concerning the procedure on the sequestration of goods pending criminal investigation, the code reads as follows:
Article 165
(1)  The authority that enforces the sequestration (sechestru) must identify and evaluate the goods in question; it may, if need be, make recourse to experts. [...]
(9)  If there is the danger of estrangement, other movables sequestered will be sealed or taken away, and a custodian can be appointed.
Article 166
(1)  The body that enforces the sequestration draws up an official report on all acts performed under Section 165, including a detailed description of the goods sequestered and specifying their value...
Article 168
(1)  Against this measure taken and of its enforcement means, the defendant, the party bearing the civil responsibility, as well as any other interested person may complain to the criminal investigation body who ordered the measure or to the prosecutor who supervises the criminal investigation, before summoning the court, after which the complaint is addressed to the relevant court.
(2)  The court decision may be appealed against separately. The appeal does not suspend the execution.
(3)  After the final settlement of the criminal trial, if no complaint has been lodged against the enforcement of the assurance measure, it may be contested under the civil law.
Article 169
(1)  If the criminal investigation body or the court finds that items taken away from the defendant, or from any other person who received them in custody, are the property of the victim or have been wrongly taken away from him/her, it orders the return of those items to the victim. Any other person who claims a right over the things taken away may ask under Article 168 for enforcement of this right and return of the items taken.
(2)  The items taken away are returned only if this does not impede the revealing of the truth and the just settlement of the cause, and imposes upon the person to whom they are returned the obligation to keep them until the decision is declared final.
43.  An overview of the law and practice concerning artificial procreation in general and on the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells in Europe is included in S. H. and Others v. Austria ([GC], no. 57813/00, §§ 35-44, 3 November 2011).